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Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population

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ClinicalTrials.gov Identifier: NCT00656383
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
The Ottawa Hospital
University of Ottawa
Information provided by (Responsible Party):
Dr. Margaret Harrison, Queen's University

Tracking Information
First Submitted Date  ICMJE April 7, 2008
First Posted Date  ICMJE April 11, 2008
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE October 2000
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
Proportion in each study arm of ulcerated limbs completely healed at 3 months [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
  • Time to complete healing, ulcer size, and ulcer recurrence over 12 months [ Time Frame: 12 months ]
  • Client function, pain and health-related quality of life [ Time Frame: 12 months ]
  • Client and provider satisfaction [ Time Frame: 12 months ]
  • Health services expenditure and utilization [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Official Title  ICMJE Effectiveness and Efficiency of Two Models of Delivering Care to a Chronic Wound Population
Brief Summary Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months. Secondary outcomes are: time to healing of all ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the number of weeks patients were free from ulcers, function, pain, and health related quality of life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics result in better healing rates, more cost-effective care, and improved client and provider satisfaction than the home visiting model.
Detailed Description

The management of chronic wounds in the community is a pressing issue for home care authorities. The care of leg ulcers represents a considerable expense to the health care system. It has been estimated that the care of venous leg ulcers alone consumes 1% of the national health care budgets of the UK and France. A one-month prevalence study in the Ottawa Carleton region (pop. 750,000) revealed that 126 Community Care Access Centre Clients (CCAC - the regional health care authority) received over 1500 home nursing visits. During the course of a year this represents more than $600,000 in home nursing visits for this condition in just one Ontario region. There is evidence supporting effective wound management but this is not necessarily what patients receive. As well, appropriate evidence-based, efficient, community-based care must be supported by ready access to specialized facilities. Research from other countries suggest that reorganization of services which includes nurse-run clinic care near to home, evidence-based protocols, and enhanced linkages with secondary and tertiary services may result in improvements in healing rates and reductions in expenditures. These international studies provide optimism that with reorganization of care within the Canadian context we can deliver community services for improved outcomes. However, only with a rigorous evaluation of the effectiveness and efficiency can we understand if such changes in the Canadian context are beneficial.

Objective:

To evaluate the effectiveness and efficiency of two models of service delivery: traditional single service delivery model (home visiting) compared to nurse-led community clinics.

Research Questions:

  1. What are the health outcomes (healing, function, plain and quality of life) for two models of care (nurse-run neighbourhood clinics vs. home care) for the population with leg ulcers?
  2. What are health services utilization and expenditures associated with the two models of care?
  3. What is client and provider satisfaction with the nurse-run neighbourhood clinics and home nursing care?
  4. What are the barriers and supports to implementing neighbourhood leg ulcer clinics?

Study Design and Method:

A randomized health services controlled trial of nurse-run neighbourhood leg ulcer clinics (intervention) and home care (current practice) with a cost-effectiveness analysis. A repeated measures design will be used to assess healing and ulcer improvement, quality of life and patient satisfaction over time.

Outcome measures:

The primary outcome measure is the proportion of limbs healed by three months. Secondary outcome measures are: time to complete healing, ulcer size, ulcer recurrence, function, pain, quality of life, client and provider satisfaction.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Varicose Ulcer
Intervention  ICMJE
  • Other: Clients randomized to nurse-led clinic
    Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol
    Other Names:
    • Usual Care
    • Best Practice
    • Venous Leg Ulcer treatment
  • Other: Clients receive leg ulcer care in their homes
    Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol
    Other Names:
    • Leg Ulcer Care
    • Usual Care
    • Best Practice
Study Arms  ICMJE
  • Active Comparator: 1
    Client is randomized to receive leg ulcer treatment in the home
    Intervention: Other: Clients receive leg ulcer care in their homes
  • Active Comparator: 2
    Client randomized to receive leg ulcer care in the clinic
    Intervention: Other: Clients randomized to nurse-led clinic
Publications * Harrison MB, Graham ID, Lorimer K, Vandenkerkhof E, Buchanan M, Wells PS, Brandys T, Pierscianowski T. Nurse clinic versus home delivery of evidence-based community leg ulcer care: a randomized health services trial. BMC Health Serv Res. 2008 Nov 26;8:243. doi: 10.1186/1472-6963-8-243.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2008)
401
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The client:

  • Admission to home care for care of a venous leg ulcer (below the knee to the foot)
  • Ability to travel to clinic
  • No major contraindication for clinic care (eg not being able to leave an ill spouse, refusal, etc.)

Exclusion Criteria:

  • Treatment is contraindicated
  • The ulcer in question is not venous
  • The client cannot travel outside the home or travel is impeded
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00656383
Other Study ID Numbers  ICMJE MOP-42497
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Margaret Harrison, Queen's University
Original Responsible Party Dr. Margaret B. Harrison, Loeb Health Research Institute
Current Study Sponsor  ICMJE Queen's University
Original Study Sponsor  ICMJE University of Ottawa
Collaborators  ICMJE
  • The Ottawa Hospital
  • University of Ottawa
Investigators  ICMJE
Principal Investigator: Margaret B Harrison, RN, PhD The Ottawa Hospital
Study Director: Ian D Graham, PhD Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus
Study Director: Philip S Wells, PhD The Ottawa Hospital
Study Director: Susan VanDeVelde, PhD Victorian Order of Nurses, Ottawa-Carleton Branch
Study Director: Judith L Threinen, BSR, MHA Ottawa-Carleton Community Care Access Centre
Study Director: Donna I Nicholson, Dip O&A Ottawa Carleton Community Care Access Centre
PRS Account Queen's University
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP